CROSS-FUSE™* II PEEK VBR/IBF SYSTEM 38-1845-15-12L

GUDID 00846468058685

Crossfuse II Hyperlordic, 18x45x15 (12°)

Pioneer Surgical Technology, Inc.

Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

• Primary Device ID: 00846468058685
• NIH Device Record Key: 6b8ddb5e-63f1-46d0-91c7-cb1c9d73845b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CROSS-FUSE™* II PEEK VBR/IBF SYSTEM
• Version Model Number: 38-1845-15-12L
• Catalog Number: 38-1845-15-12L
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00191083030319 [Primary]
GS1	00846468058685 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133623
• Premarket Notification: K170643

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-12-21

On-Brand Devices [CROSS-FUSE™* II PEEK VBR/IBF SYSTEM]

• 00846468062309: CROSSFUSE II CORONAL IMP 18x70x17 (6°C)
• 00846468062293: CROSSFUSE II CORONAL IMP 18x70x15 (6°C)
• 00846468062286: CROSSFUSE II CORONAL IMP 18x70x13 (6°C)
• 00846468062279: CROSSFUSE II CORONAL IMP 18x70x11 (6°C)
• 00846468062255: CROSSFUSE II CORONAL IMP 18x65x17 (6°C)
• 00846468062248: CROSSFUSE II CORONAL IMP 18x65x15 (6°C)
• 00846468062231: CROSSFUSE II CORONAL IMP 18x65x13 (6°C)
• 00846468062224: CROSSFUSE II CORONAL IMP 18x65x11 (6°C)
• 00846468062217: CROSSFUSE II CORONAL IMP 18x65x9 (6°C)
• 00846468062200: CROSSFUSE II CORONAL IMP 18x60x17 (6°C)
• 00846468062194: CROSSFUSE II CORONAL IMP 18x60x15 (6°C)
• 00846468062187: CROSSFUSE II CORONAL IMP 18x60x13 (6°C)
• 00846468062170: CROSSFUSE II CORONAL IMP 18x60x11 (6°C)
• 00846468062163: CROSSFUSE II CORONAL IMP 18x60x9 (6°C)
• 00846468062156: CROSSFUSE II CORONAL IMP 18x55x17 (6°C)
• 00846468062149: CROSSFUSE II CORONAL IMP 18x55x15 (6°C)
• 00846468062132: CROSSFUSE II CORONAL IMP 18x55x13 (6°C)
• 00846468062125: CROSSFUSE II CORONAL IMP 18x55x11 (6°C)
• 00846468062118: CROSSFUSE II CORONAL IMP 18x55x9 (6°C)
• 00846468062101: CROSSFUSE II CORONAL IMP 18x50x17 (6°C)
• 00846468062095: CROSSFUSE II CORONAL IMP 18x50x15 (6°C)
• 00846468062088: CROSSFUSE II CORONAL IMP 18x50x13 (6°C)
• 00846468062071: CROSSFUSE II CORONAL IMP 18x50x11 (6°C)
• 00846468062064: CROSSFUSE II CORONAL IMP 18x50x9 (6°C)
• 00846468062057: CROSSFUSE II CORONAL IMP 18x45x15 (6°C)
• 00846468062040: CROSSFUSE II CORONAL IMP 18x45x13 (6°C)
• 00846468062033: CROSSFUSE II CORONAL IMP 18x45x11 (6°C)
• 00846468062026: CROSSFUSE II CORONAL IMP 18x45x9 (6°C)
• 00846468062019: CROSSFUSE II CORONAL IMP 18x45x7 (6°C)
• 00846468062002: CROSSFUSE II CORONAL IMP 18x40x15 (6°C)
• 00846468061999: CROSSFUSE II CORONAL IMP 18x40x13 (6°C)
• 00846468061982: CROSSFUSE II CORONAL IMP 18x40x11 (6°C)
• 00846468061975: CROSSFUSE II CORONAL IMP 18x40x9 (6°C)
• 00846468061968: CROSSFUSE II CORONAL IMP 18x40x7 (6°C)
• 00846468059262: Crossfuse II Hyperlordic, 22x60x15 (12°)
• 00846468059255: Crossfuse II Hyperlordic, 22x60x13 (12°)
• 00846468059248: Crossfuse II Hyperlordic, 22x60x11 (12°)
• 00846468059224: Crossfuse II Hyperlordic, 22x55x15 (12°)
• 00846468059217: Crossfuse II Hyperlordic, 22x55x13 (12°)
• 00846468059200: Crossfuse II Hyperlordic, 22x55x11 (12°)
• 00846468059187: Crossfuse II Hyperlordic, 22x50x15 (12°)
• 00846468059170: Crossfuse II Hyperlordic, 22x50x13 (12°)
• 00846468059163: Crossfuse II Hyperlordic, 22x50x11 (12°)
• 00846468059156: Crossfuse II Hyperlordic, 22x45x15 (12°)
• 00846468059149: Crossfuse II Hyperlordic, 22x45x13 (12°)
• 00846468059132: Crossfuse II Hyperlordic, 22x45x11 (12°)
• 00846468058821: Crossfuse II Hyperlordic, 18x60x15 (12°)
• 00846468058814: Crossfuse II Hyperlordic, 18x60x13 (12°)
• 00846468058807: Crossfuse II Hyperlordic, 18x60x11 (12°)
• 00846468058791: Crossfuse II Hyperlordic, 18x60x9 (12°)